POMALYST (pomalidomide - capsule;oral)

Has a generic version of Pomalyst been approved?

No. There is currently no therapeutically equivalent version of Pomalyst available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pomalyst. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Patent use: USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA

Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drugPatent 6,045,501Issued: April 4, 2000Inventor(s): Elsayed; Marc & Williams; BruceAssignee(s): Celgene CorporationNovel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

Patent expiration dates:

August 28, 2018

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drugPatent 6,315,720Issued: November 13, 2001Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.Assignee(s): Celgene CorporationImproved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

Patent expiration dates:

October 23, 2020

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drugPatent 6,561,976Issued: May 13, 2003Inventor(s): Marc; Elsayed & Bruce; WilliamsAssignee(s): Celgene CorporationNovel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

Patent expiration dates:

August 28, 2018

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicatedPatent 6,561,977Issued: May 13, 2003Inventor(s): Bruce A.; Williams & Joseph K.; KaminskiAssignee(s): Celgene CorporationMethods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

Patent expiration dates:

October 23, 2020

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicatedPatent 6,755,784Issued: June 29, 2004Inventor(s): Bruce A.; Williams & Joseph K.; KaminskiAssignee(s): Celgene CorporationMethods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

Patent expiration dates:

October 23, 2020

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drugPatent 6,908,432Issued: June 21, 2005Inventor(s): Elsayed; Marc & Williams; BruceAssignee(s): Celgene CorporationNovel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

Patent expiration dates:

August 28, 2018

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Pharmaceutical compositions of 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-amino isoindolinePatent 8,158,653Issued: April 17, 2012Inventor(s): Muller; George W. & Stirling; David I. & Chen; Roger Shen-ChuAssignee(s): Celgene CorporationSubstituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are disclosed. The compounds are useful, for example, in reducing the levels of TNFα in a mammal.

Patent expiration dates:

August 10, 2016

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Drug product

Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dionePatent 8,198,262Issued: June 12, 2012Inventor(s): Zeldis; Jerome B.Assignee(s): Celgene CorporationMethods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

Patent expiration dates:

October 19, 2024

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Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA

Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drugPatent 8,204,763Issued: June 19, 2012Inventor(s): Elsayed; Marc & Williams; BruceAssignee(s): Celgene CorporationNovel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

Patent expiration dates:

August 28, 2018

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicatedPatent 8,315,886Issued: November 20, 2012Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.Assignee(s): Celgene CorporationMethods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

Patent expiration dates:

October 23, 2020

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drugPatent 8,589,188Issued: November 19, 2013Assignee(s): Celgene CorporationNovel methods for delivering a drug to a patient while preventing the exposure of a fetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to fetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

Patent expiration dates:

August 28, 2018

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicatedPatent 8,626,531Issued: January 7, 2014Assignee(s): Celgene CorporationMethods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

Patent expiration dates:

October 23, 2020

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Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dionePatent 8,673,939Issued: March 18, 2014Assignee(s): Celgene CorporationMethods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

Patent expiration dates:

May 15, 2023

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Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA

Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dionePatent 8,735,428Issued: May 27, 2014Assignee(s): Celgene CorporationMethods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

Patent expiration dates:

May 15, 2023

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Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dionePatent 8,828,427Issued: September 9, 2014Assignee(s): Celgene CorporationPharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.

Patent expiration dates:

June 21, 2031

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Drug substance

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Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:

February 8, 2018 - NEW CHEMICAL ENTITY

April 23, 2018 - POMALYST, IN COMBINATION WITH DEXAMETHASONE, IS INDICATED FOR PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY

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Glossary

Term

Definition

Drug Patent

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Drug Exclusivity

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

RLD

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.